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PET Scanning in Parkinson s Disease

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ClinicalTrials.gov Identifier: NCT00024622
Recruitment Status : Recruiting
First Posted : September 24, 2001
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Description
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Brief Summary:
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.

Condition or disease Intervention/treatment
Schizophrenia Parkinson's Disease Drug: 18F-Fluoro-L-dopa Drug: O-15 Water

Detailed Description:
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.
Study Design
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Study Type : Observational
Estimated Enrollment : 580 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Positron Emission Tomography (PET) Scanning in Dopamine Disorders: Parkinson's Disease and Schizophrenia
Actual Study Start Date : March 15, 2002

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy volunteers
Healthy volunteers.
 Drug: O-15 Water
Patients - Parkinsons
Patients with Parkinsons
 Drug: 18F-Fluoro-L-dopa
Drug: O-15 Water
Patients - schizophrenia spectrum disorders
Patients - schizophrenia spectrum disorders
 Drug: 18F-Fluoro-L-dopa
Drug: O-15 Water


Outcome Measures
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Primary Outcome Measures :
  1. To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation. [ Time Frame: Ongoing ]
    To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson's disease (both familial and sporadic), and those with schizophrenia spectrum disorders.
Criteria
  • INCLUSION CRITERIA:
  • Age between 18 and 90 years
  • Ability to give informed consent
  • Ability to read and write
  • Ability to give adequate medical and neuropsychiatric history.

PARKINSONS DISEASE:

  • Individuals over the age of 18 from families in which an autosomal dominant form of Parkinson's disease is suspected based on pedigree analysis.
  • Each subject will have a medical history and brief neurological examination.
  • The diagnosis in probands must be supported by accepted clinical criteria: tremor, bradykinesia, and responsiveness to L-DOPA.
  • Equivocally affected individuals will also be included in order to aid in their phenotypic classification as will at risk individuals who show no neurological signs.
  • Individuals with sporadic Parkinson's disease will also be scanned. These will be over the age of 50 years and will have no known family history of Parkinson's disease or any other movement disorder.
  • PD patients will have an admission physical exam and medical history as well as laboratory tests deemed necessary on the basis of history and physical exam.

SCHIZOPHRENIA:

- Members of this patient group will have a diagnosis of schizophrenia or schizophrenia spectrum disorder as determined by the SCID and will be currently enrolled in NIH approved protocol 89-M-0160 (Inpatient Evaluation of Neuropsychiatric Patients) under which they will have received admission work-up.

HEALTHY VOLUNTEERS:

  • A large cohort of healthy volunteers will also have a PET scan.
  • Volunteers will be age, gender and handedness-matched to patients for statistical purposes.
  • Volunteers, who are enrolled as healthy controls under protocol 95-M-0150 "Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and their Siblings" will receive admission workup through that protocol.

EXCLUSION CRITERIA:

  • Will include medical illness that would affect cerebral blood flow or dopamine
  • Current pregnancy
  • Current breast feeding
  • Possible exposure to radiation exceeding RSC guidelines
  • History of any (excepting nicotinerelated) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
  • Cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse),either in excess of 5 years total or not in remission for at least 6 months,
  • Inability to stay caffeine- and nicotine-free for 4 hours
  • Current suicidality or assaultiveness
  • History of movement disorder
  • History of head injury requiring hospitalization
  • History of coma
  • Inability to meet general safety criteria for MRI study (as determined by standardized Nuclear Medicine Research (NMR) Center screening)
  • Previously demonstrated inability or unwillingness to comply with a study protocol.

PARKINSONS DISEASE:

- Individuals not capable of understanding the consent will be excluded.

HEALTHY VOLUNTEERS:

- Healthy volunteers will be unable to participate if they have been treated with psychotropic medication within the three months prior to scanning, are undergoing current psychiatric treatment, have any history of major psychiatric or movement disorder, have a first degree relative with schizophrenia, or have a family history of PD.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024622


Contacts
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Contact: Jasmin Czarapata, Ph.D. (301) 435-7645 js733c@nih.gov
Contact: Karen F Berman, M.D. (301) 496-7603 bermank@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Karen F Berman, M.D. National Institute of Mental Health (NIMH)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00024622    
Other Study ID Numbers: 010232
01-M-0232
First Posted: September 24, 2001    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: April 5, 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Neurological Disorder
Regional Cerebral Blood Flow
Dopamine
Schizophrenia
Parkinson's Disease
Natural History
 PD
Parkinson
Healthy Control
HV
Normal Control
Additional relevant MeSH terms:
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Parkinson Disease
Schizophrenia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
 Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs